XERS - Xeris stock rises on FDA orphan drug status for hormone disorder therapy Recorlev

The U.S. Food and Drug Administration (FDA) granted orphan drug exclusivity to Xeris Biopharma's ( NASDAQ: XERS ) Recorlev to treat adult patients with endogenous Cushing's syndrome for whom surgery is not an option or has not been curative.

Xeris' unit Xeris Pharmaceuticals said that as the first approval of levoketoconazole (Recorlev) for Cushing’s syndrome, the company is entitled to seven years of orphan-drug market exclusivity from its FDA approval date of Dec. 30, 2021.

The company noted that the regulatory exclusivity is in addition to the patent exclusivity covering Recorlev's use, which extends to at least March 2040.

Cushing syndrome occurs when there is high levels of a hormone called cortisol in the body which can cause complications.

"The approval of Recorlev was based upon data from two positive Phase 3 studies that evaluated a combined study population of 166 patients and was shown to be effective for reducing and normalizing cortisol," said Xeris’ Chairman and CEO Paul Edick.

The FDA grants orphan drug status to therapies which treat or prevent rare diseases that affect fewer than 200K people in the U.S. The designation provides certain incentives, including seven years of market exclusivity, if approved.

XERS +3.17% to $1.30 premarket Jan. 30

For further details see: